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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

BRIDGE 2017.

Study characteristics
Methods RCT, active‐controlled, double‐blind
Date of study: November 2012 ‐ November 2015
Setting: 57 centres in Austria, Germany, the Netherlands and Poland
Participants Randomised: 704 participants (mean age 44.5 years, 452 male)
Inclusion criteria

  • Participants with moderate‐severe psoriasis (PASI ≥ 12, BSA ≥ 10), age ≥ 18 years


Exclusion criteria

  • Failed therapy with fumaric ester

  • Baseline leucocyte counts < 3 x 109 cells L1 and/or lymphocyte counts < 1 x 109 cells L1

  • Pregnant or breastfeeding women


Dropouts and withdrawals

  • 254/704 (36%);

  • Not treated: Dimethyl Fumarate (DMF) (1), DMF + salt of monoethyl fumarate (MEF) (3), placebo (1)

  • AEs: DMF (64), DMF + MEF (70), placebo (6)

  • Lack of efficacy: DMF (12), DMF + MEF (9), placebo (20)

  • Withdrew consent: DMF (13), DMF + MEF (11), placebo (7)

  • Lost to follow‐up: DMF (5), DMF + MEF (5), placebo (5)

  • No compliance: DMF (3), DMF + MEF (7), placebo (1)

  • Other: DMF (6), DMF + MEF (5), placebo (0)
Interventions Intervention
A. Dimethyl fumarate (DMF) (n = 280), orally, maximum daily dose of 720 mg DMF
Control intervention
B. DMF + salt of monoethyl fumarate (n = 286), orally, maximum daily dose of 720 mg DMF
C. Placebo (n = 138)
Outcomes Assessments at 16 weeks
Primary outcomes of the trial

  • PASI 75

  • PGA 0/1


Secondary outcomes of the trial

  • PASI 90

  • DLQI

  • AEs
Notes Funding source: Quote (p 1) “This research was funded by Almirall S.A.”.
Declarations of interest (p 1): "U.M. has been an advisor and/or received speaker honoraria and/or received grants and/or participated in clinical trials for the following companies: Abbott/AbbVie, Almirall Hermal, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Foamix, Forward Pharma, Galderma, Janssen, LEO Pharma, Lilly, Medac, Miltenyi Biotec, MSD, Novartis, Pfizer, Teva, UCB, VBL and XenoPort. J.C.S. receives advisory board/consulting fees from AbbVie, Biogen, Biogenetica International Laboratories, Egis Pharmaceuticals, Fresenius, LEO Pharma, Lilly, Novartis, Pierre Fabre, Polpharma, Sandoz and Toray Corporation; and receives speaker fees from AbbVie, Actavis, Adamed, Astellas, Berlin‐Chemie Menarini, Fresenius, Janssen‐Cilag, LEO Pharma, Mitsubishi Tanabe Pharma, Novartis, Pierre Fabre, Takeda and Vichy, and clinical trial funding from AbbVie, Actelion, Almirall, Amgen, GlaxoSmithKline, Janssen‐Cilag, Merck, Mitsubishi Tanabe Pharma, Novartis, Regeneron and Takeda. P.V.K. declares consultancy fees for Celgene, Centocor, Almirall, Amgen, Pfizer, Philips, Abbott, Lilly, Galderma, Novartis, Janssen‐Cilag, LEO Pharma, Sandoz and Mitsubishi Tanabe Pharma and carries out clinical trials for Basilea, Pfizer, Lilly, Amgen, AbbVie, Philips Lighting, Janssen‐Cilag and LEO Pharma. R.L."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (p 2): “Randomisation was performed by the investigators using an interactive web‐based response system.”
Comment: probably done
Allocation concealment (selection bias) Low risk Quote (p 2): “Randomisation was performed by the investigators using an interactive web‐based response system. The randomisation sequence was kept concealed from the investigators during the trial.”
Comment: probably done
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (p 2): “Treatment was uptitrated over the first 9 weeks, with placebo or up to a maximum daily dose of 720 mg DMF in the LAS41008 or Fumaderm® groups”
Comment: probably done
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote (p 2): “Treatment was uptitrated over the first 9 weeks, with placebo or up to a maximum daily dose of 720 mg DMF in the LAS41008 or Fumaderm® groups”
Comment: probably done
Incomplete outcome data (attrition bias)
All outcomes High risk Randomly assigned 704, analysed 671
Management of missing data:
Quote (p 4): “All statistical analyses were based on the full analysis set (FAS) and the per protocol set (PPS). As the results of both were consistent, data are presented here only for the FAS. A last‐observation‐carried‐forward approach was used to handle
missing data for the PASI‐ and PGA‐derived end points.”
DMF/DMF + MEF/placebo
Randomised 280/286/138
Safety set analysis 279/283/137 (not‐treated participants excluded)
Full set analysis 267/273/131 (not explained)
Comment: not ITT analysis
Selective reporting (reporting bias) High risk Comment: the protocol for the study was available on ClinicalTrials.gov (NCT01726933).
Some prespecified outcomes and those mentioned in the Methods section as DLQI had not been reported